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GlaxoSmithKline PLC committed fraud by withholding negative information and misrepresenting data on prescribing its antidepressant Paxil to children, according to a lawsuit filed Wednesday by New York Attorney General Eliot Spitzer. The lawsuit highlights two pharmaceutical and medical controversies: whether antidepressants increase suicidal tendencies in children, and if drug companies skew information on their products either by not publicizing all the studies conducted on medicines or editing information on published trials. “Having doctors prescribe drugs without full knowledge of safety and efficacy is wrong,” Spitzer said. Filed in New York State Supreme Court, the suit said Glaxo suppressed four studies that failed to demonstrate the drug was effective in treating children and adolescents and that suggested a possible increase in suicidal thinking and acts. It also said an internal 1999 Glaxo document showed that the company intended to “manage the dissemination of data in order to minimize any potential negative commercial impact.” Glaxo spokeswoman Mary Anne Rhyne said the company “acted responsibly in conducting the studies in pediatric patients and disseminating results. All of our studies have been made available to the (U.S. Food and Drug Administration) and regulators worldwide.” Rhyne also said the studies have been made public in medical meetings, journals and letters to doctors. She said the internal document is “inaccurate” and “doesn’t express the overall company position.” Only Prozac, made by Eli Lilly & Co., has been approved to treat depression in children. But doctors can prescribe drugs as they see fit and routinely recommend such medicines for children suffering from depression and other psychological disorders. However, evidence showing that antidepressants other than Prozac may not be suitable for use in children has spurred a movement to force drug companies to publish all the information they collect on their medicines. Last year, after reviewing Glaxo’s pediatric studies on Paxil, British medical authorities said it should not be used to treat depression in people under 18 because of concerns about potential suicidal behavior. British authorities also said most commonly prescribed antidepressants are not suitable for children because the risks outweigh the benefits. At an FDA meeting in February to discuss suicidal tendencies in children taking antidepressants, psychiatrist Dr. David Fassler said he was given data and studies he’d never seen before. “That raised a lot of questions,” said Fassler, who is on the board of the American Psychiatric Association. “As a physician, the easier the access to data, the more helpful I can be to my patients.” Fassler said the data he saw didn’t show a clear association with suicidal behavior. “More dramatic was how few drugs demonstrated any efficacy,” he said, and added that poor study design may have played a role in that. In March, the FDA said doctors should monitor closely all patients taking antidepressants for signs of suicidal behavior. It also asked the makers of 10 such drugs to add or strengthen suicide-related warnings to their labels. The FDA has commissioned a study to review previous pediatric clinical trials of antidepressants to search for signs of suicidal behavior, and the results are expected this summer. Meanwhile, doctors are seeking ways to improve the veracity of studies published in journals and improve access to clinical trials conducted by drug companies. A report prepared for the policy-making body of the American Medical Association recommended that the Department of Health and Human Services create a registry of all clinical trials. The report also recommends journal editors take steps to ensure that articles outline any role the study sponsor had in designing, collecting and analyzing the data. They should also make sure researchers conducting the studies can analyze and publish the data independently of the trial sponsor. Some data suggests information from drug studies may not be reliable. Last month, a Journal of the American Medical Association article that reviewed 102 clinical trials found that 50 percent of efficacy outcomes and 65 percent of harm outcomes were incompletely reported. The article concluded that trial outcomes are frequently incomplete, biased and inconsistent with protocols. The AMA’s policy-making body will debate the report next month. Currently, when a drug is approved, all the studies reviewed by the FDA to make its decision are made public. That doesn’t happen if a drug or an application for a new use is rejected. Drug companies receive a six-month patent extension if they study their treatment in children, whether or not the medicine is approved for pediatric use. A review of those studies is made public. The companies don’t need FDA approval to conduct head-to-head studies against a competitor’s product for approved uses and are under no obligation to publish them. But doctors say that kind of information would be helpful. “Negative information is a benefit to us,” said Dr. John Sneider, an internist in Illinois who worked on the report for the AMA. Spitzer said Glaxo’s revenues for Paxil prescriptions in children and adolescents totaled $55 million in 2002. The lawsuit alleges the fraud began in 1998 and seeks the return of all profits obtained by Glaxo as a result of conduct alleged in the suit. Paxil was launched in 1993 and had sales of $3 billion last year. Copyright 2004 Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.

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